Label: GOHEAL- white petrolatum ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 20, 2022

If you are a consumer or patient please visit this version.

  • Active Ingredient

    White Petrolatum USP (50%)

  • Purpose

    Skin protectant

  • Uses

    • For the temporary protection of minor cuts, scrapes, burns and sunburn.
    • Helps to temporarily protect chafed, chapped, cracked or windburned skin and lips.
  • Warnings

    For External Use Only

  • Do not use

    over deep or puncture wounds infections or lacerations. Ask a doctor

  • When using this product

    avoid contact with eyes

  • Stop use and ask a doctor

    if condition worsens or does not improve within 7 days

  • Keep out of reach of children

    if swallowed get medical help or contact a Poison Control Center right away.

  • Directions

    Apply product liberally as often as necessary

  • Inactive ingredient

    Punica Granatum Seed Oil
    Cocos Nucifera (Coconut) Oil
    Sesamum Indicum (Sesame) Seed Oil
    Neem (Azadirachta indica) leaf extract
    Citrus Reticulata (Tangerine) Peel Essential Oil
    Olea Europaea (Olive) Fruit Oil
    Aloe Vera Leaf Extract
    Moringa oleifera seed oil,

    Water

  • Package Label

    Label

  • INGREDIENTS AND APPEARANCE
    GOHEAL 
    white petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81928-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM15 g  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    PUNICA GRANATUM SEED OIL (UNII: 0UI45XV0T6)  
    SESAME OIL (UNII: QX10HYY4QV)  
    AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
    WATER (UNII: 059QF0KO0R)  
    MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)  
    CITRUS RETICULATA FRUIT OIL (UNII: 25P9H3QU5E)  
    OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81928-002-0130 g in 1 TUBE; Type 0: Not a Combination Product07/13/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/13/2022
    Labeler - Adapted Living Solutions Inc. (204297027)
    Establishment
    NameAddressID/FEIBusiness Operations
    PRAKRUTI PRODUCTS PRIVATE LIMITED876984502manufacture(81928-002)